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12th February 2021 - Press notes

Start of a clinical trial for the early treatment of patients with mild COVID-19 symptoms

Start of a clinical trial for the early treatment of patients with mild COVID-19 symptoms

The Hospital del Mar is the promoter of the Phase 2 study that will assess the antiviral efficacy of compound E-52862, produced by ESTEVE, in the early treatment of outpatients with mild COVID-19 symptoms.

The Hospital del Mar, the Pompeu Fabra University and ESTEVE are collaborating in the SIGMA4COVID Phase 2 clinical trial that the hospital, the promoter of the study, has recently initiated to determine the efficacy and safety of the compound E-52862 in the early treatment of outpatients with mild COVID-19 symptoms and confirmed infection.

Rafael_Maldonado_Jordi_Monfort_Santi_Grau

Left to right, Dr. Rafael Maldonado, Dr. Jordi Monfort and Dr. Santi Grau

ESTEVE has supplied this compound in the amount required to carry out the study and WeLab Barcelona (the research center established as a result of the alliance between ESTEVE and Leitat), led by Dr. José Miguel Vela, has collaborated in the conceptualization and design of the trial. Dr. Jordi Monfort, head of the Rheumatology Department at the Hospital del Mar, is the study's lead researcher and Dr. Rafael Maldonado, Director of the Neuropharmacology Laboratory, Department of Experimental and Health Sciences (the Pompeu Fabra University, IMIM) is the co-researcher. The Hospital del Mar Pharmacy Service is also collaborating in the study. Dr. Monfort points out that "a particularly relevant aspect is that the study will be carried out in Primary Care Centers located in the area of influence of the Parc de Salut Mar Consortium in Barcelona".

E-52862 is an investigational drug that is not yet available on the market, developed by ESTEVE's R&D team, led by Dr. Carlos Plata-Salamán, who tells "it acts on the sigma-1 receptor, a unique protein which, based on published data, shows antiviral activity in experimental studies in cells infected by the virus that causes COVID-19". According to Dr. Maldonado, "international studies recently published in prestigious journals such as Nature and Science, indicate that the sigma-1 receptor participates in viral multiplication, and suggest that drugs that are active against this receptor could be active against the virus that causes COVID-19, reducing its viral load and preventing clinical deterioration".

Specifically, the Phase 2 clinical trial will evaluate the antiviral effect of compound E-52862 on outpatients with mild symptoms of COVID-19, following positive confirmation of infection by means of a PCR test. For this purpose, in addition to receiving standard outpatient treatment, the patients, whose participation is voluntary, will be divided into two groups: one group will receive a daily dose of E-52862 for 14 days, while the control group will receive placebo instead. The SARS-CoV-2 viral load will be determined during the treatment days by comparing both groups to see if E-52862 reduces it. A lower viral load may prevent complications arising from SARS-CoV-2 infection. In addition, throughout the study, the evolution of the patients' COVID-19 symptoms will be monitored, as will their need for hospitalization and the safety of the treatment.

This clinical trial involves researchers from Hospital del Mar, Hospital del Mar Medical Research Institute (IMIM), Primary Care Centers, Pompeu Fabra University and the WeLab Barcelona Research Centre.

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